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Diltiazem Pregnancy and Breastfeeding Warnings

Diltiazem is also known as: Cardizem, Cardizem CD, Cardizem LA, Cardizem Monovial, Cardizem SR, Cartia XT, Dilacor XR, Dilt-XR, Diltia XT, Diltiazem Hydrochloride CD, Diltiazem Hydrochloride SR, Diltiazem Hydrochloride XR, Diltiazem Hydrochloride XT, Diltzac, Matzim LA, Taztia XT, Tiadylt ER, Tiazac

Medically reviewed on Mar 15, 2017

Diltiazem Pregnancy Warnings

This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk.
-Some experts recommend: Use is not recommended during pregnancy and in women of child-bearing potential who are not using effective contraception.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk summary: This drug may increase the risk of embryolethality, fetolethality, and/or stillbirths.

Comments:
-The possibility of pregnancy should be ruled out prior to starting treatment.
-Women of childbearing potential should be advised to avoid becoming pregnant while receiving this medication, and should use adequate methods of contraception throughout treatment.
-Newborns exposed to this drug should be monitored for hypoxia, especially in the event of maternal hypotension.

Animal studies have revealed evidence of embryolethality, teratogenicity, and fetolethality (e.g., skeletal/cardiac/retinal/tongue abnormalities, increased stillbirths, prolonged delivery, as well as lower pup weights and survival rates). This drug may result in decreased contraction of the uterus and decreased uterine perfusion due to peripheral vasodilation. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Diltiazem Breastfeeding Warnings

This drug is freely diffusible in milk, with concentrations in breast milk that may approximate serum levels.

Use is contraindicated.
-Some experts recommend: Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-The American Academy of Pediatrics classifies this drug as compatible with breastfeeding.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Dilacor XR (diltiazem)." Aventis Pharmaceuticals, Bridgewater, NJ.
  4. "Product Information. Cardizem (diltiazem)." Hoechst Marion-Roussel Inc, Kansas City, MO.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. Department of Adolescent and Child Health and Development. UNICEF. World Health Organization "Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. Available from: URL: http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1" ([2003]):
  3. "Product Information. Dilacor XR (diltiazem)." Aventis Pharmaceuticals, Bridgewater, NJ.
  4. "Product Information. Cardizem (diltiazem)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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